Cardiac FunctionNCT06761820
Effect the Glycemic Control on Cardiac Function
An observational study of Cardiac Function and Glycemic Control, run by Assiut University.
Trial summary
Evaluation of the effect of the Glycemic control on cardiac function in patients with type 2 diabetes mellitus Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiac Function, Glycemic Control
- What is being tested?
- Echocardiogram
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cardiology and diabetes outpatients clinics, internal medicine. Assiut University hospital.
Who may be able to join
- type 2 diabetic patients with heart diseases
Who cannot join
- patients with type 1 diabetes mellitus
- gestational DM
- CKD patients requiring haemodialysis
- Immune system disorder
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation the Effect of Glycemic Control on Cardiac Function in Patients with Type 2 Diabetes Mellitus
Evaluation of the effect of the Glycemic control on cardiac function in patients with type 2 diabetes mellitus
Read the detailed description
Type 2 Diabetes Mellitus (T2DM) is one of the most common metabolic disorders worldwide and its development is primarily caused by a combination of two main factors: defective insulin secretion by pancreatic β-cells and the inability of insulin-sensitive tissues to respond to insulin diabetes mellitus is a chronic, metabolic disease characterized by elevated levels of blood glucose, which leads over time to damage to the heart,vasculature, eyes, kidneys and nerves.
Over 90% of diabetes mellitus cases are T2DM, a conditionmarked by deficient insulin secretion by pancreatic islet β-cells, tissue insulin resistance (IR) and aninadequate compensatory insulin secretory response . Progression of the disease makes insulinsecretion unable to maintain glucose homeostasis, producing hyperglycaemia.
T2DM is a multisystem disease with a strong correlation with CVD development T2DM leads to a two- to four-fold increase in the mortality rate of adults from heart disease and is associated with both micro- and macro-vascular complications, the latter consisting of accelerated atherosclerosis leading to severe peripheral vascular disease, premature coronary artery disease (CAD) . These factors lead to T2DM being considered a significant risk factor for CVD ]. These include the role of IR in atherosclerosis, vascular function, oxidative stress, hypertension, macrophage accumulation and inflammation Factors implicated in cardiovascular risk outcomes from T2DM and the interactions between them. T2DM derived hyperglycemia, hyperinsulinemia and IR causes endothelial dysfunction, diabetic dyslipidemia and inflammation leading to atherosclerosis leading to CVD.
In addition, it is well documented that type 2 DM is associated with enhancement of platelet and hemostatic activities
Clinical trials have shown that intensive glucose control reduces the risk for microvascular complications among patients with type 2 diabetes, but its effect on CVD, including coronary heart disease (CHD), and peripheral arterial disease, is uncertain . Early data from the UKPDS (United Kingdom Prospective Diabetes Study) 34 suggested a protective effect of improved glucose control on CVD, CVD deaths, and all-causes mortality
Poor glycemic control and insulin resistance are associated with deterioration of heart failure and LV dysfunction . However, available data suggest no difference in the risk of worsening heart failure between subjecting patients to intensive glycemic control and standard treatment arms . The relationship between glycated hemoglobin (Hba1c) and LVEF remains unclear
- Conditions
- Cardiac Function, Glycemic Control
- Being tested
- Echocardiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramDevice
Echo : for evaluation anatomical and functional alteration LV and diastolic dysfunction and myocardial reserve measure by LVEF by M-mode before the study and follow up echo assessment 3 months after glycemic control
What is being measured
The primary outcome is the main question the study is designed to answer.
functional alteration of left ventricel
Echocardiography for evaluation anatomical (chamber demision by M - mode) and functional alteration LV and diastolic dysfunction and myocardial reserve measure by LVEF before the study and follow up echo assessment 3 month after glycemic control.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study startApr 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac FunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramez Gamal Shawky, Assiut University
- Investigators
- Mohamed Hossam Hassan, Professor, Study chair, Assiut UniversityHanaa Mohamed Riad, Doctor (lecture), Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761820
- Sponsor's protocol ID
- Glycemic control and EF
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Glycemic Control on Cardiac Function in Patients with Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06761820
- Acronym / sponsor ID
- Glycemic control and EF
- Conditions
- Cardiac Function, Glycemic Control
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the effect of the Glycemic control on cardiac function in patients with type 2 diabetes mellitus
Detailed description
Type 2 Diabetes Mellitus (T2DM) is one of the most common metabolic disorders worldwide and its development is primarily caused by a combination of two main factors: defective insulin secretion by pancreatic β-cells and the inability of insulin-sensitive tissues to respond to insulin diabetes mellitus is a chronic, metabolic disease characterized by elevated levels of blood glucose, which leads over time to damage to the heart,vasculature, eyes, kidneys and nerves.
Over 90% of diabetes mellitus cases are T2DM, a conditionmarked by deficient insulin secretion by pancreatic islet β-cells, tissue insulin resistance (IR) and aninadequate compensatory insulin secretory response . Progression of the disease makes insulinsecretion unable to maintain glucose homeostasis, producing hyperglycaemia.
T2DM is a multisystem disease with a strong correlation with CVD development T2DM leads to a two- to four-fold increase in the mortality rate of adults from heart disease and is associated with both micro- and macro-vascular complications, the latter consisting of accelerated atherosclerosis leading to severe peripheral vascular disease, premature coronary artery disease (CAD) . These factors lead to T2DM being considered a significant risk factor for CVD ]. These include the role of IR in atherosclerosis, vascular function, oxidative stress, hypertension, macrophage accumulation and inflammation Factors implicated in cardiovascular risk outcomes from T2DM and the interactions between them. T2DM derived hyperglycemia, hyperinsulinemia and IR causes endothelial dysfunction, diabetic dyslipidemia and inflammation leading to atherosclerosis leading to CVD.
In addition, it is well documented that type 2 DM is associated with enhancement of platelet and hemostatic activities
Clinical trials have shown that intensive glucose control reduces the risk for microvascular complications among patients with type 2 diabetes, but its effect on CVD, including coronary heart disease (CHD), and peripheral arterial disease, is uncertain . Early data from the UKPDS (United Kingdom Prospective Diabetes Study) 34 suggested a protective effect of improved glucose control on CVD, CVD deaths, and all-causes mortality
Poor glycemic control and insulin resistance are associated with deterioration of heart failure and LV dysfunction . However, available data suggest no difference in the risk of worsening heart failure between subjecting patients to intensive glycemic control and standard treatment arms . The relationship between glycated hemoglobin (Hba1c) and LVEF remains unclear
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cardiology and diabetes outpatients clinics, internal medicine. Assiut University hospital.
Key inclusion criteria (1 listed)
- type 2 diabetic patients with heart diseases
Key exclusion criteria (4 listed)
- patients with type 1 diabetes mellitus
- gestational DM
- CKD patients requiring haemodialysis
- Immune system disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiogramEcho : for evaluation anatomical and functional alteration LV and diastolic dysfunction and myocardial reserve measure by LVEF by M-mode before the study and follow up echo assessment 3 months after glycemic control | Device | – |
Primary outcome
functional alteration of left ventricel
Time frame: 3 months
Echocardiography for evaluation anatomical (chamber demision by M - mode) and functional alteration LV and diastolic dysfunction and myocardial reserve measure by LVEF before the study and follow up echo assessment 3 month after glycemic control.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Hossam Hassan, Professor study chair
Assiut University
Hanaa Mohamed Riad, Doctor (lecture) study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Function and Glycemic Control, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramez Gamal Shawky, Doctor (+201206875833, ramez2941998@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional alteration of left ventricel (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.